hello again and welcome to our gcp mindset channel and our topics on basics of clinical research today we'll talk about good clinical practices also known as gcp and what this means in clinical research why is this important stay tuned gcp is a guideline that describes international ethic and scientific quality standards designed to prepare staff and everyone involved in the conduct of clinical trials with human participants this accounts for whether the staff are located at the laboratory where blood or tissue samples are collected and assessed or even at the pharmacy where the medications or the products
are stored imaging centers radiologists physicians study nurses and even the doctors seeing the patients or even at the research organization like a cro where the study is designed the conduct of the study analysis and reporting is monitored all parties involved including sponsors staff at the trial side the contract research organizations ethics committees regulatory authorities etc they share partial tasks that good clinical practice requires the social sponsor who initiated the clinical study is the main responsible party however all the other parties need to ensure that everyone follows their task in compliance skillfully and efficiently gcp follows
the international council on harmonization or you may have heard it referred to as ica gcp this is an international quality standard that provides a unified standard across the eu united states canada australia japan and switzerland to bring a mutual acceptance of clinical trials data by regulatory authorities it's therefore widely accepted and also expected in all research involving humans and every party involved that they should complete this training or the course beforehand let's talk a little bit about the history of gcp the development of good clinical practice began at the end of world war ii following
the new back trials following which the nuremberg code was formulated for more on this please refer to our link above where we talk about ethical principles of helsinki from these instructions the ethical foundations of gcp were formed and further developed since the introduction of the declaration of helsinki all countries had their own guidelines in the his industry and you can only imagine the problems that come with everyone doing their own thing the way they would like especially when it involves the lives of patients hence a solution was created in 1996 through a series of conferences
held to unify all the processes and this meeting became known as the international conference on harmonization of good clinical practice hence the name ica gcp the first guideline was published in 1996 so ica gcp revision 1 since then revised revision 2 in november 2016. the guidelines are very detailed and categorized in several sections fitting every role in parties involved you'll also have heard of ich e-6 which is the efficacy guideline on good clinical practice iceh6 has also been revised in 2014 and then the second time in 2016. we now anticipate revision 3 which will be
a game changer in terms of innovative processes more efficient approaches and we're all excited about it there are 13 core principles of ic gcp and these principles apply to all clinical investigations that affect safety and well-being on the human participants especially in clinical trials of investigational medicinal products in europe things are slightly special the european commission made compliance with gcp a legal requirement across all the member states for all clinical trials of medicinal products therefore a directive was published in 2001 with legal framework and core principles that should be adhered to we've covered some of
our videos on regulatory pathways you can also find it using the link above so why is gcp important gcp ensures the safety rights and well-being of the patients or the subjects involved as participants in research are assured or protected the data from these patients are collected from the studies of high quality reliability and integrity before you start working in clinical trials it's crucial to take the ic gcp course of the training it's a requirement for everyone involved in the study and also ensures that all the standards ethical principles sound scientific evidence and clear detailed protocols
will be followed during the research it's therefore important to find an authorized and certified organization that will be able to also provide you with the certification that you need since in some member states in the eu these certificates need to be refreshed every so often otherwise they're rendered invalid and would cause a problem during the audits so to summarize before involving clinical research please keep in mind that as a research professional you will not only need to attain this training or the certificate but your proof of participation in ica gcp training should be to the
best of your ability in order to provide the best and the highest standard to the care of the patients that so deserve it therefore completing the modules of this training should be taken seriously so if you your organization is looking to get this training we've also provided some leads for you in the video description below see you next time goodbye hey there don't forget like subscribe but most importantly click that bell so you never miss another video
